Ever since troglitazone was pulled from the market because of hepatotoxicity,clinicians has been concerned that this may be a class effect. But a newstudy of rosiglitazone (Avandia), funded by manufacturer SmithKlineBeecham,indicates this drug is not associated with heptatotoxic effects.
Previous observational studies found that starting statins early after an MI reduces the risk of second heart attacks and death. But a new, larger observational study published last month in JAMA found no such reduction with early initiation (< 7 days)-and even an increased risk of MI or death for patients whose cholesterol levels were below treatment guideline levels.
The evidence doesn't support a link between administration of hepatitis B (HPB) vaccine and demyelinating disorders, such as multiple sclerosis (MS) and Guillain-Barré syndrome, so no change in immunization policy is warranted, according to an Institute of Medicine (IOM) report.
Eplerenone, a selective aldosterone inhibitor in phase III clinical trials,is an effective agent for reducing blood pressure in a variety of patientswith hypertension, including African-Americans, said presenters at the 17thannual scientific meeting of the American Society of Hypertension in NewYork City.
Switching from traditional nonsteroidal anti-inflammatory drugs (NSAIDs) to COX-2 selective drugs does not result in a decrease in gastrointestinal (GI) medical cotherapy. Furthermore, there is no reduction in GI healthcare costs when patients are switched from NSAIDs to selective COX-2 inhibitors, said Loren Laine, MD, at Digestive Disease Week in San Francisco.
Administrative databases are a potentially useful source of data for conducting retrospective studies. Information in such a database can be used to evaluate the effects of organizational policy changes, new programs, or pharmaceutical therapies. This month?s column reviews the six essential steps required for conducting a simple database analysis. An example involving sepsis is used to further illustrate key points.
Alefacept (Amevive) is the first immunosuppressive agent directed specifically at inhibiting the activation of, and possibly killing, T cells, which are involved in the cascade of events leading to psoriatic plaque formation and inflammation. In May, an FDA advisory committee recommended alefacept for approval as a first-line therapy against moderate to severe plaque psoriasis. The authors of this Focus article review the clinical characteristics of alefacept as well as make comparisons with other systemic drugs currently used to treat chronic psoriasis and the likely biologic competitors etanercept and infliximab.
The evidence supporting a role for the angiotensin II receptor blockers (ARBs) in patients with nephropathy and/or heart failure continues to evolve. Currently, the FDA is in late-stage review of the first ARB for a heart failure indication and is reviewing another ARB for a diabetic nephropathy indication. The authors of this article present and interpret the clinical evidence for ARB use in these two disease states. Included in their discussion are the most recent recommendations on ARBs’ place in therapy according to the American Diabetes Association, the American College of Cardiology, and the American Heart Association.
Anoka Regional Treatment Facility, Anoka, MN-This 150-bed regional treatment facility was spending over half its annual budget on atypical antipsychotic medications. In an effort to better control rising drug class costs, a market share shift analysis of the products currently in use at the facility was conducted.
Addendum questionnaire to June Focus On: Tadalafil
Addendum to June Focus On: Tadalafil
The investigational inhaled insulin product (Exubera) could prove a boon to patients with diabetes, cutting or eliminating the need for injections. So indicate findings from a phase III trial presented at the annual meeting of the American Association of Clinical Endocrinologists (AACE). For patients with type 1 diabetes, a regimen of inhaled insulin before meals and one injection at night could control blood glucose as well as or possibly better than injections alone. These results add to some phase III data presented last June that showed a small but significant number of patients with type 2 diabetes reached recommended blood glucose levels at 6 months.
FDA actions in Brief as reported June 1, 2002
The House leadership succeeded in toting up just enough votes in late June to approve a Medicare reform bill that provides some coverage of pharmaceuticals for seniors.
as reported June 1, 2002
New Indication: COX-2 inhibitor gains rheumatoid arthritis indication
New Indication: GlaxoSmithKline Indication broadened to include HIT prevention during PCI
NME:Once monthly IM injection; treats metastatic breast cancer after tamoxifen fails
NME: 7th ARB approved for hypertension
Albert Einstein Healthcare Network, Philadelphia-What are the real-world consequences of inadequate beta blocker therapy in patients with congestive heart failure (CHF)? That is what this group of clinicians at Prestige Health-a 50,000 member managed care organization in Philadelphia-set out to determine.
In studies reported this month at the European League Against Rheumatism meeting in Stockholm, the anti-TNF antibody adalimumab (D2E7) for rheumatoid arthritis is showing good long-term results, even in patients for whom other disease modifying antirheumatic drugs (DMARDs) have failed.
This Formulary supplement was produced through an unrestristed educational grant from Bayer Corporation. The views and opinions in this supplement are those of the faculty and do not necessarily reflect the views of Formulary, Advanstar Communications Inc., or Advanstar Medical Education Services. Copyright 2002 Advanstar Communications Inc. All rights reserved.
In this final installment of this series, the authors focus on the use of SSRIs in alcohol dependence, chronic pain, eating disorders, premenstrual dysphoric disorder, and sexual dysfunction. For each condition, the authors examine how well clinical trial evidence supports the application, discuss dosing and safety considerations, and provide their recommendations on preferred and alternative SSRIs, based on the weight of the evidence.
Tadalafil (Cialis) was recently deemed approvable for the treatment of erectile dysfunction (ED). When approved, it will join the widely used PDE5 inhibitor sildenafil citrate as an oral therapy for ED management. Among tadalafil?s characteristics are its rapid onset of action, a duration of action of up to 24 hours, and lack of food influence on the drug?s pharmacokinetics. In this Focus article, the pharmacologic, pharmacokinetic, and therapeutic aspects of tadalafil are reviewed and compared, when possible, with sildenafil and another investigational agent, vardenafil.
Leflunomide, etanercept, infliximab, and anakinra represent the four latest additions to the therapeutic armamentarium for rheumatoid arthritis. All four of these DMARDs have demonstrated clinical and radiographic evidence of efficacy that is changing the therapeutic approach to treatment. The authors of this article summarize the pivotal clinical trial and efficacy data up through the perimarketing period, provide the latest efficacy and safety update on these agents, discuss the financial implications of their use, and offer insights into their place in therapy.
Moxifloxacin (Avelox®) is a relatively new fluoroquinolone available in both oral and intravenous formulations. Extensive clinical analysis and postmarketing surveys suggest that moxifloxacin is safe and well tolerated.
